Perform routine and non-routine analytical testing of commercial pharmaceutical products in accordance with approved analytical methods, specifications, SOPs, and laboratory procedures.
Execute facility testing, finished product release, stability, in-process control, raw material, and other QC testing as assigned.
Operate applicable laboratory instrumentation and perform analytical techniques, including HPLC, GC, dissolution, UV-Vis, FTIR, and other technologies as qualified.
Prepare samples, standards, reagents, and solutions in accordance with approved procedures.
Accurately calculate, document, and report analytical results within established testing timelines.
Adhere to cGMP laboratory standards, Good Documentation Practices (GDocP), data integrity principles, and applicable regulatory requirements.
Complete laboratory documentation ensuring accuracy and completeness.
Review analytical data and supporting documentation for accuracy, completeness, and compliance with approved procedures.
Maintain a clean, organized, and safe laboratory environment while following applicable safety and chemical hygiene procedures.
Participate in investigations related to laboratory incidents, deviations, OOS, OOT, and other unexpected analytical results.
Assist with root cause investigations and implementation of corrective and preventive actions (CAPAs) as assigned.
Support analytical method transfers and method verification activities as assigned.
Participate in laboratory training programs and maintain required training and qualification records.
Support laboratory continuous improvement initiatives to improve testing efficiency, accuracy, compliance, and right-first-time execution.
Assist in client inquiries, regulatory inspections, audits, and other QC activities as requested by QC management.
Required Skills & Abilities
Strong understanding of cGMP laboratory practices and applicable regulatory expectations.
Knowledge of Good Documentation Practices (GDocP) and data integrity principles.
Working knowledge of analytical chemistry principles, laboratory techniques, and pharmaceutical testing practices.
Demonstrated ability to accurately execute analytical methods and laboratory procedures.
Strong mathematical, analytical, and problem-solving skills.
Ability to interpret analytical results and identify atypical or unexpected data.
Excellent attention to detail and organizational skills.
Excellent time management skills with the ability to meet testing deadlines and commercial manufacturing schedules.
Ability to prioritize multiple tasks in a fast-paced laboratory environment.
Demonstrated ability to collaborate and work effectively in cross-functional teams.
Excellent verbal and written communication skills.
Ability to communicate analytical results, testing status, and laboratory concerns effectively.
Ability to follow written procedures and work independently with appropriate oversight.
Ability to accept feedback, adapt to changing priorities, and constructively manage conflict.
Education & Experience
Bachelor’s degree in a scientific discipline or related field, with 1- 2 years of hands-on lab experience preferred; or
Master’s degree in a scientific discipline or related field, with 1 year of hands-on lab experience preferred.
Experience in pharmaceutical commercial QC testing preferred.
Physical Requirements
Prolonged periods of sitting or standing at a desk and working on a computer.
Must be able to lift up to 25 pounds at times.
Adheres to consistent and predictable in-person attendance.
